Analysis and visualization methods using manometry data

ABSTRACT

A system and methods that provide for visualization and/or characterization of manometry data. Visual representations of pressure information represent pressure information measured over time by sensors positioned within an organism. Markers may be provided on the visual representations. Using the system and methods described herein, various characteristics of an organism and/or events that occur within the organism may be determined.

RELATED APPLICATIONS

This application claims the benefit under 35 U.S.C. §120 as a divisionalapplication of U.S. application Ser. No. 11/129,030 filed May 13, 2005and entitled “ANALYSIS AND VISUALIZATION METHODS USING MANOMETRY DATA,”which claims the benefit under 35 U.S.C. §119(e) of U.S. ProvisionalApplication Ser. No. 60/571,815, entitled “ANALYSIS AND VISUALIZATIONMETHODS USING HIGH RESOLUTION MANOMETRY DATA” filed on May 17, 2004,both of which are herein incorporated by reference in their entireties.

BACKGROUND OF INVENTION

The esophagus is a tubular organ that carries food and liquid from thethroat to the stomach. It contains muscles that rhythmically contractwhenever a person swallows. This contraction generally occurs as asweeping wave carrying food down the esophagus to the stomach. Thissweeping wave of contraction is typically referred to as peristalsis. Anupper esophageal sphincter (UES) is located at an upper end of theesophagus. The UES is a muscle that serves as a valve between theesophagus and the pharynx from which the esophagus receives food andliquid when swallowing.

The lower esophageal sphincter (LES) is located at a lower end of theesophagus. The LES is a muscle that serves as a valve between theesophagus and the stomach. The LES protects the lower esophagus fromstomach acid and bile, which causes the discomfort of heartburn and intime, can damage or scar the esophagus.

The diaphragm is a muscular membrane that assists is respiration andintersects the upper Gastrointestinal (GI) tract at an approximate rightangle, typically within the length of the LES, creating a pressureinversion point (PIP), which is often referred to as the respiratoryinversion point (RIP). As used herein, an “upper GI tract” includes atleast the UES, esophagus, LES and at least portions of the pharynx andstomach. The PIP is named as such because it is a point along the lengthof the upper GI tract (typically within, but sometimes distal to, theLES) where the pressure associated with respiration inverts. Above thePIP, pressure decreases during inhalation and increases duringexhalation. In contrast, below the PIP, the pressure increases duringinhalation and decreases during exhalation. A hiatal hernia occurs ifthe PIP (i.e., the intersection of the diaphragm and the LES) is notwithin the LES, but is located below the LES within the upper regions ofthe stomach.

Manometry is the measurement of pressure. Esophageal manometry measuresthe muscular pressure exerted along the upper GI tract, for example,during peristalsis. Esophageal manometry is used to evaluate thecontraction function of the upper GI tract in many situations (e.g.,breathing, swallowing food, swallowing liquid, drinking, coughing, etc.)and can be useful for diagnosing symptoms that originate in theesophagus, for example, difficulty in swallowing food or liquid,heartburn, and chest pain to determine the cause of the symptoms, forexample, dysphasia or achalasia.

A variety of esophageal manometry systems have been used to studypressure along the upper GI tract. Such systems typically include aprobe that is inserted into the upper GI tract and one or more pressuresensors that detect pressure from different positions within the upperGI tract. One type of a probe is a catheter. An esophageal manometrysystem that has a catheter as a probe is a referred to herein as acatheter-based esophageal manometry system. Types of catheter-basedesophageal manometry systems include solid state systems and waterperfuse systems. In water perfuse systems, pressure sensors are locatedexternal to the catheter. Each pressure sensor has a corresponding tubethat extends into the catheter and pumps fluid (e.g., water) at somelongitudinal position of the catheter against the interior surfaces ofthe GI tract. The pressure resulting from the impact of the fluidagainst the interior surface is transmitted via the fluid through thetube to the pressure sensor, where it is detected. In contrast, solidstate systems do not use fluids, and each sensing element is attached toor embedded within the catheter and detects pressure locally at thepoint of impact with the interior surface of the upper GI tract. Eachsensor transmits its detected values out of the catheter using anelectronic or optical signal.

An esophageal manometry system may include or be accompanied by anapplication (e.g., software, firmware, hardware or a suitablecombination thereof) that visually indicates the values detected by thesensors to a user, and may be capable of visually indicating the valuesdetected by the sensor on a temporal representation in real time using aline trace. As used herein, a “temporal representation” is a plot havinga temporal dimension representing time, on which values detected overtime are visually indicated, concurrently, at temporal positions alongthe temporal dimension, each detected value visually indicated at atemporal location corresponding to a time at which the value wasdetected. A temporal representation is useful to concurrently illustratevalues of a physical property detected at one or more positions overtime.

As used herein, a “line trace” is a visual representation that visuallyindicates values detected over time at a location on a temporal plothaving a temporal dimension corresponding to time. For each location, abaseline for the location running parallel to the temporal dimension isindicated. The value detected at the corresponding position within theregion at each time is represented as an offset from the baseline at atemporal location along the temporal dimension that corresponds to thetime. The amount of the offset corresponds to the detected value. Eachvisually indicated value detected at the position may be connected by acontinuous line, which, depending on the detected values, may be astraight line or a curved line.

As used herein, a “contour plot” is a visual representation thatvisually indicates values detected over time at locations on a temporalplot having a temporal dimension corresponding to time and a spatialdimension corresponding to a region. A contour plot may represent to auser pressure data derived from pressure information measured by sensorsat a plurality of positions over time. A contour plot may include one ormore tones which each represent a pressure range.

SUMMARY OF INVENTION

In one aspect, the invention relates to a method of processing pressuredata including a plurality of pressure values indicative of pressureinformation measured by a plurality of sensors within a sphincter regionof an organism during a first time. The pressure data is received. Amaximum pressure value of the region for the first time is determinedfrom the pressure data.

In another aspect, the invention relates to a method of visuallyrepresenting pressure data measured over time by a plurality of sensorspositioned within an organism. A first display representing a firstregion within the organism is provided. A movable set of markers isprovided in the first display. Each marker of the movable set of markersrepresents a respective position within the first region. The movableset of markers is movable along a spatial dimension within the firstdisplay representing the first region. For each marker of the movableset of markers, a visual representation of values corresponding topressure information measured over time at the respective positionwithin the first region represented by the marker is provided. Thevisual representation of values is provided in a second displayconcurrently to providing the first display.

In yet another aspect, the invention relates to a method of locating aregion of interest within an organism using visual representations ofpressure information measured by a plurality of sensors positionedwithin the organism. A first display representing a first region withinthe organism is viewed. The first display includes a movable set ofmarkers. Each marker of the movable set of markers represents arespective position within the first region. The movable set of markersare movable along a spatial dimension within the first displayrepresenting the first region. A second display displayed concurrentlyto the first display is viewed. For each marker of the movable set ofmarkers, a visual representation of values corresponding to pressureinformation measured over time at the respective position within thefirst region represented by the marker is provided. The position of theregion of interest within the organism is determined based on theviewing of the first and second displays.

In yet another aspect, the invention relates to a method of visuallyrepresenting pressure information measured during a temporal interval bya plurality of sensors positioned within a region of an organism, eachsensor positioned at a respective position within the region. A temporalrepresentation is provided on which the pressure information is visuallyrepresented at least partially based on the pressure information. Thetemporal representation has a temporal dimension representing time and aspatial dimension representing the region. The temporal representationcomprises a first location along the spatial dimension corresponding toa first position within the region. A first set of markers is providedon the temporal representation. The first set of markers corresponds tothe first position within the region and defines a first sub-interval ofthe temporal interval. The first sub-interval corresponds to an eventrepresented by the pressure information.

In a further aspect, the invention relates to a method of visuallyrepresenting pressure information measured during a first temporalinterval by a plurality of sensors positioned at respective positionswithin a region of an organism. A first visual representation of thepressure information is provided in a temporal display. The temporaldisplay has a temporal dimension representing time and a spatialdimension representing the region. A temporal control movable along thetemporal dimension is provided in the first display. A first location ofthe temporal control along the temporal dimension indicates a first timeduring the temporal interval. A second visual representation of pressureinformation measured by the plurality of sensors at the first timeindicated by the temporal control is provided in a second display. Thesecond display is provided concurrently to the first visualrepresentation being provided.

BRIEF DESCRIPTION OF DRAWINGS

The accompanying drawings are not intended to be drawn to scale. In thedrawings, each identical or nearly identical component that isillustrated in various figures is represented by a like numeral. Forpurposes of clarity, not every component may be labeled in everydrawing. In the drawings:

FIG. 1A is a block diagram illustrating an example of a system forproviding representations of pressure data to a user;

FIG. 1B is a block diagram illustrating an example of a visualizationcomponent of the system;

FIG. 2 is a sketch illustrating the esophageal tract in the human bodyand an example of a detection component for providing esophagealmanometry data;

FIG. 3 is a screenshot illustrating an example of a user interfacedisplay at a first point in time;

FIG. 4 is a screenshot illustrating an example of a user interfacedisplay at a second point in time;

FIG. 5 is a screenshot illustrating an example of a user interfacedisplay showing an alternative representation;

FIG. 6 is a flowchart illustrating an example of a method of processingsphincter data;

FIG. 7 is a portion of a screenshot illustrating an example of a linetrace corresponding to maximum pressure values in a sphincter region;

FIG. 8 is a flowchart illustrating an example of a method of visuallyrepresenting pressure data;

FIGS. 9A and 9B are portions of screenshots illustrating examples ofline traces and corresponding markers;

FIG. 10 is a flowchart illustrating an example of a method of locating aregion of interest within an organism;

FIG. 11 is a flowchart illustrating an example of a method of visuallyrepresenting pressure information using markers;

FIG. 12 is a portion of a screenshot illustrating an example of sets ofmarkers on a contour plot;

FIG. 13 is a portion of a screenshot illustrating an example of sets ofmarkers on line traces;

FIG. 14 is a flowchart illustrating of an example of a method ofvisually representing pressure information using a movable temporalmarker;

FIG. 15 is a portion of a screenshot illustrating an example of amovable temporal marker in a first location;

FIG. 16 is a portion of a screenshot illustrating an example of amovable temporal marker in a second location;

FIG. 17 is a block diagram illustrating an example of a computer system;and

FIG. 18 is a diagram illustrating an example of data transfer.

DETAILED DESCRIPTION

A manometric analysis and visualization system for visualizing highresolution manometry data in real time is described in co-pendingapplication Ser. No. 10/281,068, filed on Oct. 24, 2002, and titled“VISUALIZATION OF VALUES OF A PHYSICAL PROPERTY DETECTED IN AN ORGANISMOVER TIME” by Tom R. Parks (hereinafter, the Parks application) which isherein incorporated by reference in its entirety.

Although aspects of the invention described below are describedprimarily in relation to visually indicating values of physicalproperties (e.g., pressure, pH level, temperature, voltage, tissueimpedance) detected from an organism (e.g., a human), or values derivedtherefrom, over time, such aspects are not limited thereto, but apply tovisually indicating any types of values over time. Further, althoughaspects of the invention described below are described primarily inrelation to visually indicating values of physical properties detectedwithin the upper GI tract, such aspects are not limited thereto, butapply to visually indicating physical properties detected within otherorgans or combinations of organs, including tubular organs, locatedwithin an organism such as, for example, the duodenum, small bowel, bileduct, colon, Sphincter of Oddi, anus or rectum. Further, such values maybe detected along a spatial dimension external to an organism, forexample, on an exterior surface of an organism.

Embodiments of the invention may employ systems and methods includingvisualization techniques, described in co-pending U.S. patentapplication Ser. No. 11/596,837 (published as US2009/0024001) titled“MANOMETRY PROBE AND DATA VISUALIZATION” by Tom Parks, filed on May 13,2005 as PCT application PCT/US2005/016809, which is hereby incorporatedby reference in its entirety.

The function and advantage of these and other embodiments of the presentinvention will be more fully understood from the examples describedbelow. The following examples are intended to facilitate anunderstanding of aspects of the present invention and their benefits,but do not exemplify the full scope of the invention.

FIG. 1A is a block diagram illustrating an example of a system 100 forvisually indicating values detected (e.g., within an organism) over aperiod of time to a user. System 100 may include any of a detectioncomponent 102, a visualization component 106, a recording medium 108, auser interface 112, other components or any suitable combination of theforegoing.

As used herein, a “user interface” is an application or part of anapplication (i.e., a set of computer-readable instructions) that enablesa user to interface with an application during execution of theapplication. A user interface may include code defining how anapplication outputs information to a user during execution of theapplication, for example, visually through a computer screen or othermeans, audibly through a speaker of other means, and manually through agame controller or other means. Such user interface also may includecode defining how a user may input information during execution of theapplication, for example, audibly using a microphone or manually using akeyboard, mouse, game controller, track ball, touch screen or othermeans.

The user interface 112 may define how information is visually presented(i.e., displayed) to the user, and defines how the user can navigate thevisual presentation (i.e., display) of information and input informationin the context of the visual presentation. During execution of theapplication, the user interface may control the visual presentation ofinformation and enable the user to navigate the visual presentation andenter information in the context of the visual presentation. Types ofuser interfaces range from command-driven interfaces, where users typecommands, menu-driven interfaces, where users select information frommenus, and combinations thereof, to GUIs, which typically take moreadvantage of a computer's graphics capabilities, are more flexible,intuitive and easy to navigate and have a more appealing “look-and-feel”than command-driven and menu-driven visual user interfaces. As usedherein, the visual presentation of information presented by a userinterface or GUI is referred to as a “user interface display” or a “GUIdisplay”, respectively.

The detection component 102 may detect pressure information of anorganism (e.g., from within an organism) over a period of time andprovide pressure data including pressure values representing thepressure information to a visualization component 106 and/or a recordingmedium 108. For example, as will be described in more detail below, ifthe pressure information is to be visually indicated in real time, thenthe pressure information is provided to at least the visualizationcomponent 106 and also may be persisted in a recording medium 108. Ifthe pressure information is not to be visually indicated in real time,but is to be visually indicated post hoc at a later point in time, thenthe detection component 102 may provide the pressure data to therecording medium 108 but not to the visualization component 106.

Visualization component 106 may be operable to receive pressure datafrom detection component 102 (e.g., for real time visual indication) andfrom recording medium 108 (e.g., for post hoc visual indication).Further, the visualization component may be operable to send data to bepersisted to the recording medium during or after visually indicatinginformation to a user. Such information may include the pressure valuesthemselves, display information such as values for display parameters,locations of anatomical landmarks, locations of a probe (e.g., catheter)with respect to an organism, interpolated values, etc. The visualizationcomponent 106 also may be operable to receive user input from userinterface 112, which may be originated from any of a variety of userinput devices (e.g., any of those described above). The visualizationcomponent 106 may include any of a variety of logic for generating datato send to the user interface 112 based on the pressure data andreceived user input.

FIG. 1B is a block diagram of visualization component 106. Visualizationcomponent 106 may be configured to perform operations on the pressuredata, provide for displaying representation(s) of the pressureinformation and/or perform other operations.

Visualization component 106 may include a maximum pressure module 114configured to process sphincter pressure data to determine one or moremaximum sphincter pressure values. For example, maximum pressure module114 may be configured to perform one or more acts of a method 700described in further detail below.

Visualization component 106 may include a region location module 116configured to display markers and temporal representations for locatinga region. For example, region location module 116 may be configured toperform one or more acts of methods 900 and/or 1000 described in furtherdetail below.

Visualization component 106 may include a location marker module 118configured to display a temporal representation and markers on atemporal representation. For example, location marker module 118 may beconfigured to perform one or more acts of a method 1300 described infurther detail below.

Visualization component 106 may include a temporal control module 120configured to display a temporal representation and a movable temporalcontrol. For example, temporal control module 120 may be configured toperform one or more acts of a method 1600 described in further detailbelow.

Visualization component 106 may include a swallow module 124 configuredto process pressure data to determine whether a voluntary swallow hasoccurred. Methods of determining whether a voluntary swallow hasoccurred are discussed below.

Visualization component 106 may include a tone control module 126configured to control tone ranges on a temporal representation (e.g., acontour plot). Methods of controlling the tone are discussed below.

Visualization component 106 may include a region identification module128 configured to process pressure data to identify a position of aregion within an organism. Methods of identifying a sphincter arediscussed below.

Visualization component 106 may include a pop-up module 130 configuredto display a temporal representation in a sub-display. Methods ofproviding the temporal representation in the sub-display are discussedbelow.

Visualization component 106 may include a line tool module 132configured to display a temporal representation and a line tool on thetemporal representation for determining characteristics of an event(e.g., a swallow). Methods of determining characteristics of an eventare discussed below.

Visualization component 106 may include a pressure baseline module 134configured to provide for the graphical selection of a location forevaluation of the corresponding gastric or esophageal baselinepressures. Methods of evaluating of pressure data using gastric oresophageal baseline pressures are discussed below.

Visualization component 106 may include a patient module 136 configuredto provide for user-controlled display of motor function events usingpatient-collected data. Methods of providing for user-controlled displayof motor function are discussed below.

System 100 and components thereof (e.g., visualization component 106)may be implemented using any of a variety of technologies, includingsoftware (e.g., C, C#, C++, Java, or a combination thereof), hardware(e.g., one or more application-specific integrated circuits), firmware(e.g., electrically-programmed memory) or any combination thereof. Oneor more of the components of system 100 may reside on a single device(e.g., a computer), or one or more components may reside on separate,discrete devices. Further, each component may be distributed acrossmultiple devices, and one or more of the devices may be interconnected.

Further, on each of the one or more devices that include one or morecomponents of system 100, each of the components may reside in one ormore locations on the system. For example, different portions of thecomponents of these systems may reside in different areas of memory(e.g., RAM, ROM, disk, etc.) on the device. Each of such one or moredevices may include, among other components, a plurality of knowncomponents such as one or more processors, a memory system, a diskstorage system, one or more network interfaces, and one or more bussesor other internal communication links interconnecting the variouscomponents. System 100, and components thereof, may be implemented usinga computer system such as that described below in relation to FIGS. 17and 18.

FIG. 2 is a sketch illustrating an example of a detection component 102.The detection component 102 may include any of detection logic 206,transmission medium 204, a plurality of sensors 205 and a probe (e.g.,catheter) 202 to which the sensors 205 may be attached or in which thesensors 205 may be embedded. The sensors 205 may be any of a variety oftypes of sensors, for example, pressure sensors such as a capacitivepressure sensors. For example, sensors 205 may be an array of sensors asdescribed in patent Cooperation Treaty application Ser. No. 10/493,459titled “Array Sensor Electronics” by Son et al., published on Mar. 31,2005 (hereinafter the Son PCT application). Such pressure sensors may becapable of detecting pressure in response to contact with tissue of anorganism.

The transmission medium 204 may be any of a plurality of types oftransmission media, such as a group of wires (e.g., a bus), a wire, acable, an optical fiber, a group of optical fibers or a wirelesstransmission medium (e.g., carrier waves through air). The transmissionmedium 204 may carry control and addressing signals from the detectionlogic to the sensors 205 and may carry detected values from the sensors205 to the detection logic 206.

In an embodiment, the plurality of sensors 205 are a linear array of sixor more sensors, for example, twenty-two or more sensors such asthirty-six sensors, or even more. If there are thirty-six sensors, thetransmission medium 205 may include six input wires and six outputwires, and the detection logic 206 may be configured to control themultiplexing of detected values along the output wires. For example, adetection cycle may be divided into six sub-cycles, where, for eachsub-cycle, six detected values are received on six respective outputlines. Thus, after six sub-cycles the values detected by all 36 sensorshave been read. For each sub-cycle, the detection logic may use one ofthe six input lines to select six of the thirty-six sensors. In anaspect of the invention, a detection cycle has a frequency greater thanfifteen hertz, for example, forty hertz or greater such as two hundredhertz, or even more. Accordingly, in such aspects where signals detectedby thirty-six sensors are being multiplexed during six sub-cycles, thefrequency of the sub-cycles may be greater than ninety hertz, forexample, two hundred forty hertz or greater such as 1.2 kilohertz oreven greater.

The detection logic 206 also may include signal processing logic toprocess the signals carrying the values received over transmissionmedium 204. For example, the signal process logic may include noisefiltering logic, analog-to-digital conversion logic and other logic toconvert the raw detected values into suitable form to be input tovisualization component 106. Detection logic 206 may include any of thelogic described in the Son PCT application.

As is shown in FIG. 2, the probe 202 and sensors 205 of the detectioncomponent 102 may be inserted into a human 208 or another organism. Forexample, the probe may be inserted through the nasal cavity 219 into theupper GI tract such that at least a portion of the probe 202 resides inthe pharynx 210, the UES 212, the esophagus 214, the LES 216 and thestomach 218. Although FIG. 2 illustrates the probe inserted within theupper GI tract, the probe may be inserted in any of a variety ofcombination of organs, including tubular organs. For example, the probe202 may be inserted in the duodenum, the small bowel, the bile duct, thecolon, the Sphincter of Oddi, the urethra, the anus or the rectum.

Each sensor may be arranged to be spaced a predefined distance from anearest one or more other sensors. Optionally, the spacing between eachpair of sensors may be configured to be approximately the same. In anaspect of the invention, this same spacing may be three centimeters orless, for example, two centimeters or less such as one centimeter, oreven less than one centimeter.

The sensors 205 may be configured to sense any of a variety of physicalproperties, for example, pressure, pH, temperature, voltage, tissueimpedance, another physical property or any combination thereof.

FIG. 3 is a screenshot illustrating an example of a user interfacedisplay 300, which may be provided by user interface 112. In thisexample, display 300 includes two displays for providing visualrepresentations of pressure data to a user: temporal display 310 andsnapshot display 320. Temporal display 310 may be a display having botha temporal dimension and a spatial dimension, and may contain a temporalrepresentation, e.g., contour plot 302. Snapshot display 320 may be adisplay having spatial dimension, including a spatial visual axis, andmay contain a spatial representation, e.g., profile plot 304 thatillustrates pressure data (or other data) for a particular time, asopposed to over a period of time.

Contour plot 302 may be displayed on a left-side of temporal display310. Contour plot 302 may represent to a user pressure data derived frompressure information measured by sensors (e.g., sensors 205) at aplurality of positions over time. In the example shown in FIG. 3, theplurality of positions for which the pressure data are represented tothe user may represent positions within the esophageal tract at whichsensors 205 are positioned. In this example, the horizontal dimension ofcontour plot 302 represents time and the vertical dimension represents afirst spatial dimension (e.g., within an organism).

In contour plot 302, the pressure data may be represented by multipletones corresponding to multiple ranges of pressure values thatcorrespond to the pressure data. Each tone may represent a respectiverange of pressure values. The size (i.e., granularity) of the ranges maybe uniform. The uniform granularity of the ranges of pressure values mayvary, and may be so fine that the spectrum of tones seems continuous tothe human eye. A tone may be any suitable visual differentiatingcharacteristic. For example, each tone may be any of a variety of colorsor shades of gray, or any other suitable visually differentiatingcharacteristic. Display 300 may include a tone bar 306, for example, onthe left side of contour plot 302. The tone bar may be a legend whichmaps a tone to a corresponding pressure range. For example, in someembodiments, the color blue may represent a low pressure range and thecolor red may represent a high pressure range. Tone bar 306 may assistusers in determining the pressure values corresponding to tonesdisplayed in contour plot 302.

Some aspects of the invention may provide for multiple tone ranges forpressure data represented in different regions of temporalrepresentation 310. A control may allow for switching between theranges. For example, the user may define one range to be in a relativelysmall range of pressure values to provide higher pressure resolution ina pressure range of interest. Another range may be defined for anotherregion, e.g., a wide pressure interval for viewing a region with a widerrange of pressure values at a lower pressure resolution.

Any suitable type of temporal representation may be used in place ofcontour plot 302 for viewing pressure values measured at a plurality ofmeasurement positions over time. For example, the temporalrepresentation may be a three-dimensional plot, a shaded contour plot, amesh plot, or any other suitable type of plot.

Display 300 may include a profile plot 304 in snapshot display 320.Profile plot 304 may represent pressure data derived from pressureinformation measured at a plurality of measurement positions at aparticular time. In FIG. 3, this pressure data is represented using aprofile line trace 312, in which pressure values of the pressure dataare represented by the horizontal offset of the profile line trace 312from a vertical spatial axis 306. Snapshot display 320 may contain anysuitable spatial representation in place of profile plot 304 thatrepresents pressure data derived from pressure information measured at aplurality of measurement positions at a particular time, e.g., tonescorresponding to pressure, bars having lengths corresponding topressures, etc.

Snapshot display 320 may have displayed along the vertical spatialdimension a representation of a region within an organism where sensorsare located to collect data. For example, profile plot 304 may include arepresentation of the esophageal tract. In FIG. 3, the pharynx,esophagus and stomach are represented along the vertical spatialdimension, centered along axis 308. The locations of these organs withrespect to the vertical spatial dimension may correspond with theirrespective positions in an actual esophageal tract. In some embodiments,profile plot 304 may include tags that represent other features of theesophageal track. For example, tags may be included at locations withinsnapshot display 320 to represent positions of the UES, the LES, and thePIP.

In some embodiments of the invention, the temporal representation 302may move horizontally along the temporal dimension to illustrate thepassage of time during the temporal interval in which the pressurevalues being represented were measured. For example, the right-most edgeof temporal representation 302 may correspond to a latest time of thetimes during the temporal interval being represented in temporalrepresentation 302, and the left-most edge may represent an earliesttime. To illustrate the passage of time during the temporal interval,the temporal representation 302 may continually shift to the left acrossthe screen, thus allowing a user to view a representation of pressuresmeasured in the esophagus over time. This continuous shift to the leftenables users to see changes in pressure (if any) over time at thepositions being represented, and may enable users to see the occurrenceof an event (e.g., a peristaltic wave) in which the pressure informationwas measured (e.g., in the upper GI tract).

For example, in temporal representation 302, a visual representation ofthe pressures in the GI tract during a swallow may be displayed. A usermay determine that a swallow has occurred by viewing the portions oftemporal representation 302 that contains tones indicative of a highpressure wave. For example, portion 303 of temporal representation 302may represent a swallow (i.e., peristaltic wave). This swallow begins atthe portion of temporal representation 302 that is in the same verticallocation as the UES marker in pressure profile plot 304. As time movesforward (toward the right in the temporal dimension, the representationitself moving left), the representation of the swallow can be seenprogressing down the esophagus to the LES.

It should be appreciated that the “time” represented by a location alonga temporal dimension of temporal display 310 (and other temporaldisplays discussed herein) does not necessarily correspond to a preciseinstant of time, but may correspond to a discrete, atomic, sub-intervalof time within the interval of time being represented. By “atomic”, whatis meant is that the sub-interval represented may be the smallest unitinterval of time being represented. For example, the smallest units oftime being represented may be milliseconds. The pressure data (or otherdata) represented at a particular temporal location in a temporaldisplay may be data detected within the atomic subinterval (i.e., time)represented by the location. Moreover, the pressure information(represented by the pressure data) detected at different positionsduring this sub-interval may have actually been detected at differenttimes during the sub-interval. For example, pressure information may bemeasured, for two or more different sensors, at different times within asub-interval represented by a temporal location in a temporal display.

Further, in some embodiments, at least some of the temporal locationsmay represent a time at which no pressure information was actuallymeasured. The pressure values displayed at these locations may be valuesinterpolated or otherwise determined based on pressure values ofadjacent locations or other locations in the temporal display. Pressurevalues may be interpolated in a temporal and/or spatial dimension. Insome embodiments, the pressure data may be made quasi-continuous in thetemporal and/or spatial dimension even though pressures may be detectedat discrete times and/or positions. Pressure data may be madequasi-continuous by including interpolated pressure values in thepressure data. A quasi-continuous visual representation (e.g., havingsmooth changes) may be provided based on quasi-continuous pressure data.Any suitable visual representation discussed below may bequasi-continuous. Viewing a quasi-continuous visual representation mayfacilitate locating aspects of a region (e.g., the UES, LES, and PIP)and placing markers at locations, and interpreting the visualrepresentation.

FIG. 4 is a screenshot illustrating an example of a temporalrepresentation 402, similar to representation 302, but shifted in time(to the left). Temporal representation 402 may be what a user would seeseveral seconds after viewing the temporal representation 302illustrated in FIG. 3. Thus, FIGS. 3 and 4 illustrate a temporalrepresentation progressing horizontally to the left as time movesforward.

FIG. 5 illustrates an example of a temporal display 310 representingpressure information measured over time in the upper GI tract. Temporaldisplay 310 may represent the same pressure data as shown in FIG. 4.FIG. 5 shows in temporal display 310 line trace representation 502,which may include several line traces. Each line trace 504, 506, 508,510, 512, 514 and 516 may represent pressure data corresponding topressure information detected by a sensor at a particular positionwithin an esophagus. Each position may correspond to a respective marker526, 528, 530, 532, 534, and 536 of snapshot plot 320, each of which maybe selected and movable by a user. At each particular time along thetemporal dimension, the height of a line trace above a baseline locationrepresents a value of the pressure information measured at the position(within the esophageal track) represented by the line trace at theparticular time.

The elements displayed in FIGS. 3-5 and described above are presented toprovide context for, and a better understanding of, embodiments of theinvention described herein. These embodiments will now be described.

It may be desirable to determine characteristics of the organism usingsystem 100 and provide a visual representation to a user. For example,it may be desirable to determine the maximum pressure in a sphincterregion of an organism at a particular time. The maximum pressure may beused to determine a barrier property of a sphincter muscle. One knownway of determining the maximum pressure in a sphincter region of anorganism is to use a Dent sleeve.

A Dent sleeve is an apparatus that uses perfuse water pressure sensingtechnology, and incorporates a sleeve along a length (e.g., 5 cm) of acatheter pressure probe. A Dent sleeve is configured such that themaximum pressure along the length of the sleeve is converted into anelectrical signal representing the maximum pressure for a measurementinterval. A Dent sleeve may be used, for example, to characterize thebarrier properties of sphincter muscles by placing the Dent sleeve suchthat it spans a sphincter region. It may be difficult to position theDent sleeve precisely within the sphincter region. If the Dent sleeve isnot positioned precisely, the sleeve may output an electrical signalthat is not representative of the maximum pressure of a sphincter regionas intended, but rather of another muscle, for example.

In one aspect of the invention, the maximum sphincter pressure may bedetermined using system 100, as will now be described in relation toFIGS. 6 and 7.

FIG. 6 is a flowchart illustrating an example of a method 700 ofdetermining maximum pressure values detected within a region (e.g., asphincter region) of an organism during a temporal interval. Method 700may be implemented at least partially using maximum pressure module 114.In one embodiment of the invention, an eSleeve may be provided using themethod shown in FIG. 6. As its name implies, unlike the Dent sleeve, an“eSleeve” is not an actual physical sleeve separate from the probe(e.g., catheter) that measures the pressure information and determines amaximum pressure value. Rather, pressure information is included withinthe pressure information collected by the probe, and the maximumpressure value may be determined by components (e.g., 106) of system100.

In act 702, the system may receive sphincter pressure data representingpressure information measured during a temporal interval at a pluralityof positions within a sphincter. The sphincter pressure data may bereceived in any suitable way via any suitable transmission media. Anysuitable component and/or module may receive the sphincter pressuredata, e.g., maximum pressure module 114 of visualization component 106.

In act 704, for each of a plurality of times during the temporalinterval, a maximum sphincter pressure value detected at any of thepositions at the time may be determined, for example, by comparing thepressure values within a specified region. The pressure values may becompared using maximum pressure module 114.

In act 706, a visual representation of the maximum pressure valuesdetermined for each time may be provided, for example, in eSleeve trace602 described below in relation to FIG. 7. It is to be appreciated thatany suitable representation of maximum pressure values may be used,e.g., a bar graph, a line trace, a contour plot, other representationsor any suitable combination of the foregoing.

FIG. 7 is a portion of a screenshot illustrating a portion of profileplot 304 and a portion of line trace representation 502. Within theportion of profile plot 304, the eSleeve boundary 606 may be demarcatedby markers 604. Each of eSleeve boundary markers 604 may be configuredto be movable by a user along a spatial baseline (e.g., axis) ofpressure profile plot 304. This ability to move the boundary markers mayenable the user to selectively delimit the eSleeve boundary 606, andplace the eSleeve boundary 606 precisely on the region of interest(e.g., a sphincter) and avoid inclusion of other anatomical regions.

One or more guidelines (not shown) may be provided within a temporalrepresentation (e.g., a contour plot and/or line trace representation502) for determining the location for eSleeve boundary marker 604. Aguideline may be provided at a location on the temporal representationwhich corresponds to the position within the region represented byeSleeve boundary marker 604. As a user moves eSleeve boundary marker 604along the spatial dimension of pressure profile plot 304, the guidelinemay move accordingly along the spatial dimension of the temporalrepresentation. The guideline may enable a user to determine thelocation for eSleeve boundary marker 604 that corresponds with theposition of an appropriate region of interest (e.g., a sphincterregion).

Line trace representation 502 also includes an eSleeve trace 602. TheeSleeve trace 602 represents the maximum pressure in the sphincterregion 606 over the time illustrated in line trace representation 502.For each time, the maximum pressure within the sphincter region 606 maybe determined (e.g., by maximum pressure module 114) by comparing aplurality of values of the pressure information measured within thisregion (e.g., a sphincter) at the time.

Method 700 may include additional acts. Further, some or all of the actsmay be performed concurrently to other acts, and need not necessarily beperformed in the order described above.

Having thus described a method 700 of determining maximum pressurevalues detected within a region (e.g., a sphincter region) of anorganism during a temporal interval, a method 900 of representingpressure data measured over time within an organism will now bedescribed.

FIG. 8 is a flowchart illustrating an example of a method 900 ofrepresenting pressure data measured over time within an organism toassist a user in locating a PIP, LES, UES or other area of interestwithin the esophageal tract. Method 900 may be implemented at leastpartially using region of interest location module 116.

Method 900 may enable a user to determine, based on pressure valuesmeasured at a plurality of positions in an organism over time, one ormore aspects of an organism. For example, the user may be enabled tolocate the UES, LES the PIP or other area of interest in the upper GItract. Visual representations of pressure information corresponding topositions represented by a user-movable set of markers may be providedthat enable a user to visually determine a position of such a region ofinterest. By moving the movable set of markers, the user may control thevisual representation of pressure data, which may facilitate finding theposition of the region of interest.

In act 902, the system 100 may provide a first display representing afirst region within an organism may be provided.

In act 904, a movable set of markers may be provided in the firstdisplay, for example as shown in FIGS. 9A and 9B.

FIGS. 9A and 9B depict one way in which an area within an organism maybe represented by moving a movable set of markers. FIG. 9A shows amovable set of markers 810 that includes three markers spaced a fixeddistance apart from one another: first marker 802, second marker 804,and third marker 806. Any suitable number of markers may be included inthe movable set of markers, e.g., greater or less than three. As usedherein, the term “fixed distance apart” means that the distance betweenany two markers in the movable set of markers does not change as any onemarker of the set is moved, e.g., in the process of locating an aspectof the organism. That is, the markers are only moveable as a set—whenone marker of the set is moved, the other markers are moved a samedistance in a same direction.

In the embodiment shown in FIGS. 9A and 9B, the movable set of markersis located in profile plot 304, on which the location of each markeralong the vertical dimension represents a position along a spatialdimension within the organism. It should be appreciated that the movableset of markers could be located in any of a variety of other suitablelocations indicative of position within the organism.

In act 906, and concurrently to providing the first display, a visualrepresentation of values corresponding to pressure information may beprovided in the second display. For each marker in the movable set ofmarkers, there may be provided in temporal display 310 a visualrepresentation of values corresponding to pressure information measuredover time at the respective position along the spatial dimension of theorganism represented by each marker. As shown in FIGS. 9A and 9B, threeline traces 812, 814, and 816 may be provided in display 310 for markers802, 804, and 806, respectively, shown in display 320. Each line tracerepresents values corresponding to pressure information measured overtime at the position represented by the corresponding marker. By viewingand comparing the line traces, a user may determine the position of anarea of interest within the organism, for example, as described below inrelation to FIG. 10.

Method 900 may include additional acts. Further, some or all of the actsmay be performed concurrently to other acts, and need not necessarily beperformed in the order described above.

FIG. 10 is a flowchart illustrating an example of a method 1000 oflocating a region of interest within an organism, e.g., the PIP, LES, orUES within the esophageal tract. In act 1002, a user may view a firstdisplay representing a first region within an organism. For example, auser may view profile plot 302 as illustrated in FIG. 9A.

In act 1004, the user may view, in a second display displayedconcurrently to the first display, visual representations of pressuredata. For example, a user may view temporal display 310 as illustratedin FIG. 9A.

In act 1006, the user may determine the position of the region ofinterest based on the viewing of the first and second displays. Anysuitable criteria may be used to determine the position of the region ofinterest, and criteria for determining the position may depend on thetype of region, e.g., UES, PIP, LES, etc.

In one aspect of the invention shown in FIG. 9A, the user may desire tolocate the PIP within the upper GI tract of a human body. By selectingand moving tag 820 or any of markers 802, 804 and 806 (which are a fixeddistance apart from one another), the user may move the movable set ofmarkers to a first location along the vertical dimension of profile plot304. In response to the moving of the movable set of markers to thefirst location, each of line traces 812, 814, and 816 may be updatedaccordingly.

As shown in FIG. 9A, each of the line traces 812, 814, and 816 aresubstantially periodic and substantially in phase with one another. Linetraces 812, 814, and 816 may be substantially periodic because thepressures in the esophageal change in response to respiration, which maybe substantially periodic. A phase shift between two periodic waveformshaving the same period may correspond to the temporal shift between thewaveforms' respective maxima. As used herein, waveforms are said to be“in phase” if the phase shift between the waveforms is negligible.Because line traces 812, 814, and 816 are substantially in phase in FIG.9A, a user may determine that each of the positions represented by therespective markers is on the same side of the PIP.

If a waveform is inverted, the inverted waveform may be phase-shifted by180° with respect to the original waveform. As discussed above, the PIP(the pressure inversion point) is named as such because it is a pointalong the length of the upper GI tract (typically within, but sometimesdistal to, the LES) where the pressure associated with respirationinverts. The PIP is also known as the RIP (respiratory inversion point),and as used herein the two terms PIP and RIP have equivalent meanings.

Line traces corresponding to pressures located below the PIP may bephase-shifted by approximately 180° with respect to line tracescorresponding to pressures located above the PIP. A user may determinethe position of the PIP by moving the movable set of markers until thereis approximately a 180° phase shift between two line traces shown indisplay 310. The user, upon viewing two line traces which are phaseshifted by approximately 180°, may determine the PIP to be at a positionbetween the positions represented by the markers that correspond to thetwo line traces.

For example, the line traces 812′, 814′, and 816′ may be displayed as aresult of a user moving markers 802, 804, and 806, respectively to thelocations shown in FIG. 9B. In FIG. 9B, first line trace 812′ and thirdline trace 816′ are approximately 180° phase-shifted from one anotherbecause the maximum of first line trace 812′ is shifted a time intervalof approximately half of the period of the waveforms from the maximum ofthird line trace 816′. Upon viewing the approximately 180° phase shiftbetween first line trace 812′ and third line trace 816′, the user maydetermine that the PIP is between the positions within the esophagealtract represented by first marker 802 and third marker 806 in FIG. 9B.

A movable set of markers may be used to determine the position ofanother aspect of an organism, such as the UES or LES. In oneembodiment, a sphincter may be located using a movable set of markersand viewing the corresponding line traces as discussed above. However,instead of looking for a phase shift between different line traces, asphincter may be located by viewing the pressure values indicated by theline traces.

A line trace of representing pressure information at a position withinthe upper GI tract may have periodic minima (i.e., “respiratory cycleminima”) resulting from a respiratory cycle. The position of the LES maybe defined as the position in the esophagus having a maximum value forrespiratory cycle minima. For example, in temporal display 310 of FIG.9A (assuming for the sake of illustration that the pressure informationbeing represented corresponds to an LES region, not a PIP region asindicated in snapshot display 320), the minima of line trace 816 aregreater than the minima of line trace 814. If, upon moving the movableset of markers to several different locations, a user does not observe aline trace with greater minima that those of line trace 816, theposition of the LES may be determined to be the position within theesophageal tract corresponding to marker 806.

As another example, the position of the UES may be defined as theposition in the upper GI tract, e.g., during a temporal interval duringwhich a swallow or other event is not occurring. The position of the UESmay be found using the movable set of markers as well. The UES may notdisplay respiratory cycle variations—so the sphincter center may bedefined as the position of maximum mean pressure. The movable set ofmarkers may be used to locate such a position.

As discussed above, interpolated pressure values may be generated.Interpolated pressure values may represent pressure information forpositions within the upper GI tract between positions of sensors 205.Providing pressure data that includes interpolated pressure values mayenable the display of a visual representation (e.g., a temporalrepresentation and/or snapshot display) of pressure information which isquasi-continuous. A quasi-continuous representation of pressureinformation may allow a user to determine a precise location for amarker (e.g., markers 528, 530, and 532) with respect to the spatialdimension (e.g., of snapshot display 320 and/or temporal display 310).Thus, providing interpolated pressure values may allow for more precisedetermination of the position of an aspect of an organism than wouldotherwise be possible (i.e., with pressure data having “discrete”spatial resolution). This aspect of the invention is not limited tofinding an aspect of an organism, but may also be applied to otherembodiments, e.g., determining a location for an eSleeve boundary marker604.

Method 900 may include additional acts. Further, some or all of the actsdescribed above with respect to FIG. 10 may be performed concurrently toother acts, and need not necessarily be performed in the order describedabove.

Having thus described a system and methods for representing pressuredata and locating a region of interest using a movable set of markerswith respect to FIGS. 8-10, another aspect of the invention will now bedescribed with respect to FIGS. 11-13.

In another aspect of the invention, one or more sets of markers on atemporal display may be used to illustrate the occurrence of an eventwithin an organism. One or more markers may be displayed on a temporalrepresentation in temporal display 310. A set of such markers maycorrespond with a position within a region of interest and may define atemporal sub-interval. The temporal sub-interval defined by the set ofmarkers may correspond to an event represented by pressure information.In some embodiments, the markers of the set of markers are movable by auser in a temporal dimension of the temporal representation. Forexample, a user may move one or more of the set of markers so that thetemporal sub-interval defined by the set of markers more accuratelycorresponds with the corresponding event.

FIG. 11 is a flowchart illustrating an example of a method 1300 ofvisually representing pressure information. Method 1300 may beimplemented at least partially using location marker providing module118. In act 1302, the system may provide a temporal representation. FIG.12 is a screenshot illustrating an example of a portion of a contourplot 1110 which may be displayed in temporal display 310. Contour plot1110 may have displayed thereon a set of markers 1102, and may includeother sets of markers (not shown). Markers 1102 may correspond to aposition within the upper GI tract represented by guideline 1104, andmay define a temporal sub-interval 1106 corresponding to a peristalticwave.

In FIG. 12, the set of markers 1102 includes three markers, but it is tobe appreciated that any suitable number of markers greater or less thanthree may be used. The leftmost marker of the set of markers 1102 maydefine the beginning of temporal sub-interval 1106. The rightmost markerof the set of markers 1102 may define the end of temporal sub-interval1106. The middle marker of the set of markers 1102 may indicate a timewithin temporal sub-interval 1106 at which a maximum pressure wasmeasured for temporal sub-interval 1106.

In some situations, the location of one or more markers of the set ofmarkers 1102 may be controlled by system 100, for example, byvisualization component 106. Visualization component 106 may beconfigured to apply one or more algorithms to determine points in timeindicated by the markers based on one or more criteria. For example, thebeginning of the temporal sub-interval may be determined based on apressure value exceeding a threshold value, the end of the sub-intervalmay be determined based on a pressure value below a threshold valueafter the beginning, and the middle may be determined based on a maximumpressure value between the beginning and the end. Any suitable criteriamay be used to determine points in time indicated by the markers.

In some situations, a user may move one or more of the markers to alocation representing a different point in time, for example,horizontally along the temporal dimension of contour plot 1110. The usermay do so to align the markers with points in time (e.g., defining asub-interval) the user believes are associated with an event.

In some embodiments, visualization component 106 may first determinepoints in time associated with an event and position markers at thedetermined points in time. A user then may move one or more of themarkers to more accurately correspond with points in time associatedwith an event.

As discussed above, the system 100 may provide for displaying differenttemporal representations that represent the same pressure data indifferent ways. For example, a contour plot and a line tracerepresentation may represent the same pressure data. FIG. 13 is ascreenshot illustrating an example of a line trace representation 1210that represents the same pressure data as is represented by contour plot1110 in FIG. 12. In this example, the peristaltic wave to which markers1102 correspond at the position represented by guideline 1104 isrepresented by line trace representation 1210. A set of markers 1202corresponding to the position represented by guideline 1104 define thetemporal sub-interval 1106 corresponding to the peristaltic wave. In oneexample, user interface 112 enable a user to switch (i.e., toggle)between viewing contour plot 1110 and line trace representation 1120 intemporal display 310. Providing markers on a contour plot 1110 and/or aline trace representation 1120 to correspond with an event may assist auser in locating the occurrence of an event, and may facilitatediagnoses.

In act 1306, the system may provide a first set of markers on thetemporal representation. Act 306 may be performed by location markerproviding module 118, and may provide markers as discussed in theexamples above. Method 1300 may include other acts. Further, some or allof the acts described above with respect to FIG. 11 may be performedconcurrently to other acts, and need not necessarily be performed in theorder described above.

In one aspect of the invention, the system 100 (e.g., visualizationcomponent 106 and/or other components) may determine a characteristic ofan event occurring within sub-intervals defined by a plurality of setsof markers based on the locations corresponding to the sets of markers.For example, the system may calculate a peristaltic wave front velocityusing the locations of the leftmost markers in two sets of markers. Theperistaltic wave velocity may be determined as the difference betweenthe respective positions represented by the two sets of markers dividedby the difference in the points in time represented by two leftmostmarkers. As another example, the system may determine a sphincterrelaxation pressure. One definition of the sphincter relaxation pressuremay be the lowest average pressure for any three second period during aswallow event. However, other suitable definitions of sphincterrelaxation pressure may also be used. If the sphincter relaxationpressure is to be determined using the above definition, the system 100may provide user-movable guide for finding the three second period. Anysuitable guide may be used, e.g., a box on the temporal representation aset of guidelines on the temporal representation.

Any of a variety of other suitable characteristics may be determinedbased on locations of markers.

Having thus described a system and methods for illustrating theoccurrence of an event within an organism using one or more set ofmarkers, another aspect of the invention will now be described withrespect to FIGS. 14-16.

In one aspect of the invention, it may be desirable to visuallyrepresent pressure information by providing a user-movable temporalcontrol. A representation of pressure data at one particular time may beprovided based on the location of the movable temporal control, thusallowing a user to choose a time for which the pressure information isto be visually represented in snapshot display 320. For example, amovable temporal control provided in temporal display 310 may be movedby a user to a location along the temporal dimension of the temporaldisplay corresponding to a particular time. Based on the location of themovable temporal control, the system may provide in snapshot display 320a visual representation of pressure information measured by theplurality of sensors at the time indicated by the movable temporalcontrol.

FIG. 14 is a flowchart illustrating an example of a method 1600 ofvisually representing pressure information in a snapshot displaycorresponding to the location of a movable temporal control in atemporal display. Method 1600 may be implemented at least partiallyusing temporal control module 120.

In act 1602, a first visual representation of pressure information maybe provided in a temporal display. FIG. 15 is a screenshot illustratingan example of a temporal display 310 in which is displayed contour plot1406 and a snapshot display 320 in which is displayed pressure linetrace 1404.

In act 1604, the system may provide, in the first display, a temporalcontrol movable along the temporal dimension. A temporal control 1402 isillustrated in temporal display 310 as a vertical line spanning thevertical dimension of display 310. However, it should be appreciatedthat any of a variety of other types of temporal controls may be usedsuch as, for example, a control marker or a sliding bar. Temporalcontrol 1402 may be movable horizontally by a user to select a temporalinterval.

In act 1606, the system may provide, concurrently to providing the firstvisual representation, in a second display, a second visualrepresentation of pressure information measured by the plurality ofsensors at the first time indicated by the temporal control. Snapshotdisplay 1404 displays a pressure line trace representing pressure datameasured at a plurality of positions measured at the time indicated bytemporal control 1402.

FIG. 16 is a screenshot illustrating the same contour plot 1406 as shownin FIG. 15; however, temporal control 1402 is in a different locationand represents a different time than in FIG. 15. In this example,snapshot display 320 includes a different pressure line trace than thatshown in FIG. 15. In FIG. 15, snapshot display 320 includes pressureline trace 1504 which represents pressure data measured at a pluralityof positions measured at the time indicated by temporal control 1402 inFIG. 16.

Method 1600 may include additional acts. Further, some or all of theacts described above with respect to FIG. 14 may be performedconcurrently to other acts, and need not necessarily be performed in theorder described above.

Some aspects of the invention may process pressure data from the pharynxor more proximal sites to determine the occurrence of a voluntaryinitiation of a swallow. The initiation may be determinedalgorithmically by recognizing and analyzing abrupt rises and falls ofpressure in regions above the UES such as the oropharynx or the base oftongue. Such detection may include identification of pressure changes ofat least a certain magnitude that take place over no more than a certainnumber of seconds. This aspect of the invention may be useful indetermining initiation of swallows to identify in a clinical study datarecord, and in determination of unprovoked (or spontaneous) swallows.The aspect may eliminate the need for a dedicated swallow transducer(typically a microphone type device), which is required in knownsystems.

Some aspects of the invention may include comparative sphincter positionidentification algorithms. These algorithms may compare the relativeproperties of pressure information measured at adjacent positions (e.g.,by adjacent sensors) within an organism. The adjacent channels maycorrespond to a region in which a sphincter is located. The displaylocations may correspond to actual positions at which pressure wasmeasured or to locations for which interpolated data has been estimated.Such interpolation may enable the representation of a spatiallycontinuous relationship of pressure and time in a temporal display suchthat sphincter positions (e.g., as identified by the followingalgorithms) may be determined using an arbitrarily small spatialquantization.

Aspects of the invention are not limited to the following techniques forlocating sphincter positions and other phenomena, as other techniquesmay be used.

Example Methods:

-   -   a. LES Method #1: Position where the respiratory cycle minimum        pressure is a maximum. Pressure information detected at adjacent        positions may be compared and the position at which the        respiratory cycle minimum pressure is a maximum identified.    -   b. LES Method #2: Position where the respiratory cycle mean        pressure is a maximum. Pressure information detected at adjacent        positions may be compared and the position at which the        respiratory cycle mean pressure is a maximum identified.    -   c. LES Method #3: Position where the end expiratory phase of the        respiratory cycle is a minimum is a maximum. Pressure        information detected at adjacent positions may be compared and        the position at which the respiratory cycle minimum is a maximum        identified.    -   d. LES Method #4: Positions extracted from the curve of the        position of maximum pressure as described in Method #8 below.        Such positions may include the spatial average, median, the most        proximal, or most distal points of the curve, or some        combination thereof.    -   e. UES Method: Position where the pressure within the adjacent        channel region is a maximum.

Some aspects of the invention may implement additional methods. Suchmethods may compute various parameters from sphincter pressure data:

-   -   a. Minimum Pressure: Finds the minimum pressure or filtered        minimum pressure over a period of time (e.g., represented by a        link trace) at a specific position. Embodiments include        computing and reporting the average (evenly or unevenly        weighted) of the lowest pressures including n % of the record        during the observation period, where n may be fixed or specified        by the user. Another embodiment includes taking an average of        respiratory cycle minima during a time period.    -   b. Mean Pressure: Finds the mean pressure over a period of time        at a particular position.    -   c. Maximum Pressure: Finds the maximum pressure or filtered        maximum pressure over a period of time at a particular position.        Embodiments include computing and reporting the average of the        highest pressures including n % of the record during the time        period where n may be fixed or specified by the user. Another        embodiment includes taking an average of respiratory cycle        maxima during the time period.

Another aspect of the invention may effect a trace sub-display (e.g., apop-up display) layered on the contour plot main display, which may beused for fine adjustment of a pressure wave or sphincter featuremarkers. In an embodiment of this method, pointers in the line trace andthe contour modes are graphically similar to assist in correlationbetween the modes. In another embodiment, the sub-display is verticallyaligned with the corresponding location on the contour display and thepointers for both display modes are visible to further assist in thecorrelation.

In another aspect, quantitative data from temporal representation 310may be displayed using a line drawing tool. Position, pressure, and timedata from both the starting and end points of the line may be displayed.The tool also may support the computation of differential changesbetween the two points and global characteristics of the data enclosedby a geometric shape, e.g., defined by a diagonal line. The differentialchanges may include Δs/Δt (wave velocity), Δp/Δt (rate of change ofpressure), Δp/Δs (pressure gradient, where Δ is the difference in therespective variable evaluated at the endpoints, and s, t, and p areposition, time and pressure, respectively). The global characteristicsof the data enclosed by the geometric shape may include computed maximumpressure, minimum pressure, average pressure, and median pressure. Theenclosed shape may be a rectangle, ellipse, another shape or acombination of the foregoing.

Yet another aspect of the invention may provide for the graphicalselection of location for evaluation of the gastric or esophagealbaseline pressures. The locations may be specified using a slidingpointer in the pressure profile, a sliding pointer at the margin orwithin the main contour display, a grid line within the main contourdisplay, or any combination thereof. A baseline marker may be ahorizontal line that is movable by a user vertically within temporalrepresentation 310. Selection of a proper location for evaluation of thegastric and esophageal baselines may be important because the baselinevalues may be incorrect if evaluated at a location that is not farenough away from sphincter muscles or other sources of pressure. Themethod may provide a control for the normalization of the display datawith respect to gastric, esophageal, or atmospheric pressure.

Evaluation of the acquired data relative to reference pressure levelsmay facilitate diagnostic evaluation of the esophagogastric junction(gastric baseline), peristaltic motor function within the esophagus(esophageal baseline), and the pharynx (atmospheric), for example. Aproperty of a region within an organism may be determined by normalizinga region pressure to a baseline pressure. For example, a pressurebarrier property of the LES region may be determined by subtracting agastric baseline pressure value from a pressure associated with the LES.

A further aspect of the invention may provide for user-controlleddisplay of motor function events using patient-collected data. Forexample, the system may display data of two classes: background andevent. Background data may typically represent a quasi-steady-statecondition such as is the case for a relaxed patient who is breathingnormally. Event data may be derived from some transient event such as aswallow, cough, or spasm (including achalasia). The user may command abackground and then command specific events that interrupt thebackground and display the corresponding transient event sequence. Thebackground and/or events may reflect normal and/or abnormal(pathological) patient conditions.

In one embodiment of this aspect, the background and events are from thesame patient or from patients with similar anatomy. The apparentposition of the anatomy relative to the probe is adjusted in the dataset if necessary such that the anatomical landmarks shown in the twoclasses of data are aligned or nearly aligned. In this case the eventappears to happen approximately as it would under a continuouslycollected data set as the displayed sequence transitions from backgroundto event.

In another embodiment of this aspect, the background data is repeatedfor every respiratory cycle or multiple respiratory cycles where the endof the background cycle is in respiratory phase with the beginning ofthe event. This further may make the transition from background to eventappear to be continuous. This aspect of the invention may be useful foreducational purposes in studying normal and abnormal patient conditions.A sequence of such conditions may be shown in an efficient manner andthe salient spatio-temporal-manometric relationships identified andcompared. This aspect also may be useful in training a user in operationof a manometric data collection system and related clinical procedures.

Methods described herein, acts thereof and various embodiments andvariations of this method and these acts, individually or incombination, may be defined by computer-readable signals tangiblyembodied on or more computer-readable media, for example, non-volatilerecording media, integrated circuit memory elements, or a combinationthereof. Computer readable media can be any available media that can beaccessed by a computer. By way of example, and not limitation, computerreadable media may comprise computer storage media and communicationmedia. Computer storage media includes volatile and nonvolatile,removable and non-removable media implemented in any method ortechnology for storage of information such as computer readableinstructions, data structures, program modules or other data. Computerstorage media includes, but is not limited to, RAM, ROM, EEPROM, flashmemory or other memory technology, CD-ROM, digital versatile disks (DVD)or other optical storage, magnetic cassettes, magnetic tape, magneticdisk storage or other magnetic storage devices, other types of volatileand non-volatile memory, any other medium which can be used to store thedesired information and which can accessed by a computer, and anysuitable combination of the foregoing.

Communication media typically embodies computer-readable instructions,data structures, program modules or other data in a modulated datasignal such as a carrier wave or other transport mechanism and includesany information delivery media. The term “modulated data signal” means asignal that has one or more of its characteristics set or changed insuch a manner as to encode information in the signal. By way of example,and not limitation, communication media includes wired media such as awired network or direct-wired connection, wireless media such asacoustic, RF, infrared and other wireless media, other types ofcommunication media, and any suitable combination of the foregoing.

Computer-readable signals embodied on one or more computer-readablemedia may define instructions, for example, as part of one or moreprograms that, as a result of being executed by a computer, instruct thecomputer to perform one or more of the functions described herein,and/or various embodiments, variations and combinations thereof. Suchinstructions may be written in any of a plurality of programminglanguages, for example, Java, J#, Visual Basic, C, C#, or C++, Fortran,Pascal, Eiffel, Basic, COBOL, etc., or any of a variety of combinationsthereof. The computer-readable media on which such instructions areembodied may reside on one or more of the components of any of systemsdescribed herein, may be distributed across one or more of suchcomponents, and may be in transition therebetween.

The computer-readable media may be transportable such that theinstructions stored thereon can be loaded onto any computer systemresource to implement the aspects of the present invention discussedherein. In addition, it should be appreciated that the instructionsstored on the computer-readable medium, described above, are not limitedto instructions embodied as part of an application program running on ahost computer. Rather, the instructions may be embodied as any type ofcomputer code (e.g., software or microcode) that can be employed toprogram a processor to implement the above-discussed aspects of thepresent invention.

It should be appreciated that any single component or collection ofmultiple components of a computer system, for example, the computersystem described in relation to FIGS. 17 and 18 that perform thefunctions described herein can be generically considered as one or morecontrollers that control such functions. The one or more controllers canbe implemented in numerous ways, such as with dedicated hardware and/orfirmware, using a processor that is programmed using microcode orsoftware to perform the functions recited above or any suitablecombination of the foregoing.

Various embodiments according to the invention may be implemented on oneor more computer systems. These computer systems, may be, for example,general-purpose computers such as those based on Intel PENTIUM-typeprocessor, Motorola PowerPC, Sun UltraSPARC, Hewlett-Packard PA-RISCprocessors, or any other type of processor. It should be appreciatedthat one or more of any type computer system may be used to convert textto speech and/or edit speech on a portable audio device according tovarious embodiments of the invention. Further, the software designsystem may be located on a single computer or may be distributed among aplurality of computers attached by a communications network.

A general-purpose computer system according to one embodiment of theinvention is configured to perform convert text to speech and/or editspeech on a portable audio device. It should be appreciated that thesystem may perform other functions and the invention is not limited tohaving any particular function or set of functions.

For example, various aspects of the invention may be implemented asspecialized software executing in a general-purpose computer system 1700such as that shown in FIG. 17. The computer system 1700 may include aprocessor 1703 connected to one or more memory devices 1704, such as adisk drive, memory, or other device for storing data. Memory 1704 istypically used for storing programs and data during operation of thecomputer system 1700. Components of computer system 1700 may be coupledby an interconnection mechanism 1705, which may include one or morebusses (e.g., between components that are integrated within a samemachine) and/or a network (e.g., between components that reside onseparate discrete machines). The interconnection mechanism 1705 enablescommunications (e.g., data, instructions) to be exchanged between systemcomponents of system 1700. Computer system 1700 also includes one ormore input devices 1702, for example, a keyboard, mouse, trackball,microphone, touch screen, and one or more output devices 1701, forexample, a printing device, display screen, speaker. In addition,computer system 1700 may contain one or more interfaces (not shown) thatconnect computer system 1700 to a communication network (in addition oras an alternative to the interconnection mechanism 1705.

The storage system 1706, shown in greater detail in FIG. 18, typicallyincludes a computer readable and writeable nonvolatile recording medium1801 in which signals are stored that define a program to be executed bythe processor or information stored on or in the medium 1801 to beprocessed by the program. The medium may, for example, be a disk orflash memory. Typically, in operation, the processor causes data to beread from the nonvolatile recording medium 1801 into another memory 1802that allows for faster access to the information by the processor thandoes the medium 1801. This memory 1802 is typically a volatile, randomaccess memory such as a dynamic random access memory (DRAM) or staticmemory (SRAM). It may be located in storage system 1706, as shown, or inmemory system 1704, not shown. The processor 1703 generally manipulatesthe data within the integrated circuit memory 1704, 1802 and then copiesthe data to the medium 1801 after processing is completed. A variety ofmechanisms are known for managing data movement between the medium 1801and the integrated circuit memory element 1704, 1802, and the inventionis not limited thereto. The invention is not limited to a particularmemory system 1704 or storage system 1706.

The computer system may include specially-programmed, special-purposehardware, for example, an application-specific integrated circuit(ASIC). Aspects of the invention may be implemented in software,hardware or firmware, or any combination thereof. Further, such methods,acts, systems, system elements and components thereof may be implementedas part of the computer system described above or as an independentcomponent.

Although computer system 1700 is shown by way of example as one type ofcomputer system upon which various aspects of the invention may bepracticed, it should be appreciated that aspects of the invention arenot limited to being implemented on the computer system as shown in FIG.17. Various aspects of the invention may be practiced on one or morecomputers having a different architecture or components that that shownin FIG. 17.

Computer system 1700 may be a general-purpose computer system that isprogrammable using a high-level computer programming language. Computersystem 1700 may be also implemented using specially programmed, specialpurpose hardware. In computer system 1700, processor 1703 is typically acommercially available processor such as the well-known Pentium classprocessor available from the Intel Corporation. Many other processorsare available. Such a processor usually executes an operating systemwhich may be, for example, the Windows® 95, Windows® 98, Windows NT®,Windows® 2000 (Windows® ME) or Windows® XP operating systems availablefrom Microsoft Corporation, MAC OS System X available from AppleComputer, the Solaris Operating System available from Sun Microsystems,UNIX available from various sources or Linux available from varioussources. Many other operating systems may be used.

The processor and operating system together define a computer platformfor which application programs in high-level programming languages arewritten. It should be understood that the invention is not limited to aparticular computer system platform, processor, operating system, ornetwork. Also, it should be apparent to those skilled in the art thatthe present invention is not limited to a specific programming languageor computer system. Further, it should be appreciated that otherappropriate programming languages and other appropriate computer systemscould also be used.

One or more portions of the computer system may be distributed acrossone or more computer systems (not shown) coupled to a communicationsnetwork. These computer systems also may be general-purpose computersystems. For example, various aspects of the invention may bedistributed among one or more computer systems configured to provide aservice (e.g., servers) to one or more client computers, or to performan overall task as part of a distributed system. For example, variousaspects of the invention may be performed on a client-server system thatincludes components distributed among one or more server systems thatperform various functions according to various embodiments of theinvention. These components may be executable, intermediate (e.g., IL)or interpreted (e.g., Java) code which communicate over a communicationnetwork (e.g., the Internet) using a communication protocol (e.g.,TCP/IP).

It should be appreciated that the invention is not limited to executingon any particular system or group of systems. Also, it should beappreciated that the invention is not limited to any particulardistributed architecture, network, or communication protocol.

Various embodiments of the present invention may be programmed using anobject-oriented programming language, such as SmallTalk, Java, C++, Ada,J# (J-Sharp) or C# (C-Sharp). Other object-oriented programminglanguages may also be used. Alternatively, functional, scripting, and/orlogical programming languages may be used. Various aspects of theinvention may be implemented in a non-programmed environment (e.g.,documents created in HTML, XML or other format that, when viewed in awindow of a browser program, render aspects of a graphical-userinterface (GUI) or perform other functions). Various aspects of theinvention may be implemented as programmed or non-programmed elements,or any combination thereof.

Having now described some illustrative embodiments of the invention, itshould be apparent to those skilled in the art that the foregoing ismerely illustrative and not limiting, having been presented by way ofexample only. Numerous modifications and other illustrative embodimentsare within the scope of one of ordinary skill in the art and arecontemplated as falling within the scope of the invention. Inparticular, although many of the examples presented herein involvespecific combinations of method acts or system elements, it should beunderstood that those acts and those elements may be combined in otherways to accomplish the same objectives. Acts, elements and featuresdiscussed only in connection with one embodiment are not intended to beexcluded from a similar role in other embodiments. Further, for the oneor more means-plus-function limitations recited in the following claims,the means are not intended to be limited to the means disclosed hereinfor performing the recited function, but are intended to cover in scopeany equivalent means, known now or later developed, for performing therecited function.

Use of ordinal terms such as “first”, “second”, “third”, etc., in theclaims to modify a claim element does not by itself connote anypriority, precedence, or order of one claim element over another or thetemporal order in which acts of a method are performed, but are usedmerely as labels to distinguish one claim element having a certain namefrom another element having a same name (but for use of the ordinalterm) to distinguish the claim elements.

What is claimed is:
 1. A method of visually representing physiologicaldata measured over time by a plurality of sensors positioned in anorganism, comprising: (A) providing a first display representing aregion in an organism; (B) providing movable markers in the firstdisplay, each movable marker representing in the region a respectiveposition in the organism, the movable markers being movable along aspatial dimension within the first display representing the region in anorganism; and (C) concurrently to step (A), providing in a seconddisplay, for each marker in the first display, a visual representationof physical property measured over time at the position in the regionrepresented by the marker.
 2. The method as in claim 1, wherein themovable markers are spaced a fixed distance apart from each other alongthe spatial dimension.
 3. The method as in claim 1, further comprising:(D) in response to moving a movable marker to a different position inthe first region, providing in the second display, for the movablemarker, a visual representation of physiological values measured overtime at the different position.
 4. The method as in claim 1, whereinstep (C) comprises providing, in the second display, for each movablemarker, a line trace corresponding to physiological values measured overtime at the position represented by the marker.
 5. The method of claim1, further comprising: (D) locating a sphincter region using the firstand second displays.
 6. The method as in claim 1, further comprising:(D) providing, in the second display, a visual control module enabling auser to move movable markers along the spatial dimension.
 7. The methodas in claim 6, comprising moving a movable marker by a user.
 8. Themethod as in claim 1, wherein step (C) comprises providing in the seconddisplay a visual representation of physiological information at leastpartially based on interpolated physiological values, the interpolatedphysiological values representing physiological information forpositions in the organism between positions of the sensors.
 9. Themethod as in claim 1, wherein the physiological values are selected froma group consisted of pressure values, temperature values, pH values,temperature values and impedance values.
 10. The method as in claim 9,further comprising locating a pressure inversion point using the firstand second displays.
 11. The method as in claim 9, further comprisinglocating a region of interest in the organism.
 12. The method as inclaim 11, where locating the region of interest comprises determiningthe position of the region of interest in the organism from informationviewable in the first and second displays.
 13. The method as in claim11, wherein locating the region of interest in the organism comprises:viewing, in the second display, a first visual representation ofpressure values over time at a position represented by a first movablemarker, and viewing a second visual representation of pressure valuesmeasured over time at a position represented by a second movable markerof the movable set of markers.
 14. The method as in claim 13, whereindetermining the position of the region of interest in the organism fromthe first and second displays comprises determining that the firstvisual representation is substantially 180° phase-shifted with respectto the second visual representation.
 15. The method as in claim 14,wherein determining the position of the region of interest in theorganism from the first and second displays comprises determining,based, at least partially, on the determination that the first visualrepresentation is substantially 180° phase-shifted with respect to thesecond visual representation, whether a pressure inversion point isbetween the position represented by the first movable marker and theposition represented by the second movable marker.
 16. The method as inclaim 13, wherein determining the position of the region of interest inthe organism from the first and second displays comprises determining,at least partially based on the visual representation, a first position,represented by a movable marker, corresponding to a maximum restingpressure.
 17. The method as in claim 16, wherein determining theposition of the region of interest in the organism from the first andsecond displays comprises determining, based at least partially on thedetermination of the first position, that a sphincter is located at thefirst position.
 18. The method as in claim 13, wherein locating theregion of interest in the organism comprises determining, at leastpartially based on a visual representation, a position represented by amovable marker, which corresponds to a maximum of respiratory cyclepressure minima.
 19. A system for visually representing pressure datameasured over time by a plurality of sensors positioned within anorganism, the system comprising: a region location module configured to,provide a first display representing a region in an organism; providemoveable markers in the first display, each movable marker representinga position in the region and movable along a spatial dimension in thefirst display; and provide in a second display, for each movable marker,a visual representation of physiological values measured over time at aposition in the region represented by the movable marker.
 20. Acomputer-readable medium storing instructions that, when executed by acomputer, cause the computer to perform a method of visuallyrepresenting, on a display device, pressure data measured over time by aplurality of sensors positioned within an organism, the methodcomprising: (A) providing a first display representing a region withinthe organism; (B) providing movable markers in the first display, eachmovable marker representing a position in the region, the movablemarkers movable along a spatial dimension in the first display; and (C)concurrently to step (A), providing in a second display, for eachmovable marker, a visual representation of pressure information measuredover time at the position in the region represented by the movablemarker.